Oramed(US:ORMP)2025-05-15 20:06Financial Performance - Revenues for the three months ended March 31, 2025, were $2,000 thousand, compared to $0 for the same period in 2024, indicating a significant increase[28]. - The net loss for the three months ended March 31, 2025, was $7,642 thousand, compared to a net income of $1,534 thousand for the same period in 2024, marking a shift in performance[28]. - Operating loss for the three months ended March 31, 2025, was $4,500 thousand, compared to a loss of $2,962 thousand for the same period in 2024, indicating worsening operational performance[28]. - The company reported a basic loss per share of $0.19 for the three months ended March 31, 2025, compared to a profit of $0.04 per share in the same period of 2024[28]. - The Company recognized financial income (expenses) of ($3,616) for the three months ended March 31, 2025, compared to $3,552 for the same period in 2024[97]. - The company incurred aggregate losses of approximately $184,258,000 from inception through March 31, 2025[205]. Assets and Liabilities - Total assets decreased to $147,539 thousand as of March 31, 2025, from $155,278 thousand as of December 31, 2024, representing a decline of approximately 5.6%[24]. - The total stockholders' equity decreased to $139,894 thousand as of March 31, 2025, from $145,347 thousand as of December 31, 2024, a decline of about 3.7%[24]. - As of March 31, 2025, total current assets were approximately $131.5 million, with total current liabilities of approximately $5.5 million, resulting in a working capital surplus of approximately $126 million[208]. - Cash and cash equivalents increased to $74,516 thousand as of March 31, 2025, from $54,420 thousand at the end of 2024, showing a growth of approximately 37%[34]. - Total net cash used in operating activities was $3,519 thousand for the three months ended March 31, 2025, compared to $1,476 thousand for the same period in 2024, indicating increased cash outflow[34]. - As of March 31, 2025, the company had fully repaid the entire amount of $99.55 million borrowed under short-term borrowings[213]. Research and Development - Research and development expenses rose to $2,206 thousand for the three months ended March 31, 2025, up from $1,179 thousand in the same period of 2024, reflecting increased investment in R&D[28]. - Research and development expenses increased by 87% to approximately $2,206,000 for the three months ended March 31, 2025, compared to approximately $1,179,000 in 2024[198]. - The company plans to initiate a revised Phase 3 trial (ORA-D-013-3) and expects to increase research and development expenses accordingly[206]. - Research and development expenses are expected to remain the major operating expense in the upcoming years, potentially borne by OraTech if clinical trials are conducted through them[215]. Joint Ventures and Collaborations - The Company incorporated a wholly-owned subsidiary, Oramed NewCo, Inc. ("OraTech"), in Nevada on July 1, 2024, for a joint venture with Hefei Tianhui Biotech Co., Ltd. ("HTIT")[37]. - The initial closing of the JV Agreement with HTIT will involve an investment of $40,000 from HTIT and $7,500 from the Company into OraTech, with the Company transferring all its intellectual property rights[41]. - The second closing of the JV Agreement, contingent on Nasdaq listing approval, involves an additional $20,000 investment from HTIT and $7,500 from the Company[42]. - Due to U.S.-China trade tensions, HTIT is currently unable to obtain necessary regulatory approvals, causing delays in the JV Agreement closing and impacting supply and manufacturing support[45]. - The Company has paused plans to initiate the Phase 3 clinical trial in the U.S. while exploring alternative partners and pathways to advance the program independently[46]. - The closing of the JV Agreement is on hold, and plans for a Phase 3 clinical trial in the U.S. have been paused pending further clarity[153]. Financial Agreements and Investments - The Company holds a senior secured promissory note from Scilex with a principal amount of $101,875, maturing on March 21, 2025, bearing interest of SOFR plus 8.5%[70]. - The Company has the right to receive 4% royalties on net sales of ZTlido and SP-103 for 10 years, as part of the Royalty Purchase Agreement[85]. - The Company acquired 50% of the Purchased Receivables, which entitles it to 4% royalties on net sales from Scilex products[85]. - The Company entered into a Profit Sharing Loan Agreement, providing NIS 5.5 million ($1,523) to finance a real estate project, with potential returns of 20% annual interest or 40% of project profits[99]. - A loan agreement was entered into on March 24, 2025, for $22,650 to finance a real estate asset in Jerusalem, with a 12% annual interest rate[118]. - The Company entered into a loan agreement with Tova Chochma for $5,000 at an annual interest rate of 12%, with a maturity extended to up to 12 months[119]. Stock and Shareholder Activities - The Company granted 1,023,540 RSUs to employees during the three months ended March 31, 2025, with a total fair value of $2,465,430[123]. - The Company recognized stock-based compensation expense of $197 for PSUs granted to executive officers, reflecting the achievement of the first updated performance target[127]. - The Company has authorized a stock buyback program with a maximum value of $20,000, which expires in June 2025, but has not repurchased any shares under this program as of March 31, 2025[128][129]. - The company has authorized a stock buyback program with a maximum value of $20 million, which may be executed through various means over the next 12 months[220]. Market and Economic Conditions - The company faces risks related to changes in trade policy and economic conditions in the U.S., which could adversely affect its ability to consummate joint ventures[218]. - An unfavorable tariff environment may amplify macroeconomic headwinds, negatively impacting revenues, profitability, and growth prospects[219].